Conformis iTotal Cruciate Retaining recall
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Why was Conformis iTotal Cruciate Retaining recalled?
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: 0469247 Exp. 2021-01-31
- Product
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
- Recalling firm
- Conformis, Inc.
- Quantity
- 1 kit
- Distribution
- NV
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)